Altamira Therapeutics Announces Publication of Positive Results from Clinical Trial with Bentrio in House Dust Mite Allergy in Leading Peer Reviewed Journal
HAMILTON, BERMUDA, July 17, 2023 (GLOBE NEWSWIRE) -- -Detailed results from house dust mite trial published in Clinical and Translational Allergy
-Study demonstrates statistically significant alleviation of nasal symptoms of allergic rhinitis
Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq: CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced the publication of the detailed results from its clinical trial with Bentrio® nasal spray in house dust mite (“HDM”) allergic rhinitis. The peer-reviewed article was published in Clinical and Translational Allergy, one of the leading journals in the field of allergology.
The HDM trial enrolled 37 patients in Canada with a history of perennial allergic rhinitis ("PAR") who underwent controlled allergen exposure three times in a challenge chamber for three hours each. They were randomly assigned in an open label crossover design to receive either Bentrio in a single or double dose, or no treatment, prior to allergen exposure.
The primary endpoint was the change in the Total Nasal Symptom Score (TNSS; determined in 20-minute intervals) from baseline. The ANCOVA (analysis of covariance) model demonstrated that Bentrio treatment reduced the increase in mean TNSS during the 3-hour exposure by 1.1 points (-1.87 to -0.28 in the 95% confidence interval; p<0.01) vs. no treatment. Under Bentrio treatment, the mean TNSS was 4.1 points vs. 5.2 points under no treatment. Administering two sprays rather than one puff did not yield any additional treatment benefits, confirming that a single application provides ample protection. A significant majority (86%) of study participants rated global tolerability of the treatment as good or very good.
“The positive results from the house dust mite challenge study nicely complement those from the grass pollen study, demonstrating significant protective effects regardless of the type of inhaled allergen particles,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO. “Also, in both studies Bentrio exhibited a lasting protective effect for several hours, reflecting its long nasal residence time. As demonstrated in a previously published study, Bentrio provides a protective film on the nasal mucosa for about 3.5 hours which far exceeds the residence time of saline nasal spray, the current standard-of-care in drug-free allergic rhinitis management.”
About House Dust Mite Allergies
HDM allergens constitute the prime cause of respiratory allergies (i.e. allergic rhinitis and allergic asthma), with prevalence estimates for allergen sensitization ranging between 65 and 130 million persons in the general population worldwide, or as much as 50% among asthmatic patients.2 In the US population aged 6 years and older, dust mite allergens are the second most common source of sensitization right after plant-related allergens (20.3 and 27.1%, respectively).3 Unlike plant-related allergens, which tend to be seasonal (e.g. pollen / hay fever), HDMs may be present all year long. Symptoms of HDM allergies include sneezing, a runny or stuffy nose, itching, coughing, difficulty breathing, and chest tightness or pain.
About Altamira Therapeutics
Altamira (Nasdaq:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/
Forward-Looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, Altamira’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira’s product candidates, the clinical utility of Altamira’s product candidates, the timing or likelihood of regulatory filings and approvals, Altamira’s intellectual property position and Altamira’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira’s Annual Report on Form 20-F for the year ended December 31, 2022, and in Altamira’s other filings with the Securities Exchange Commission (“SEC”), which are available free of charge on the SEC’s website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira or to persons acting on behalf of Altamira are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
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